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The QRESEARCH Advisory Group draws up
the criteria for access that are applied by the QRESEARCH Scientific Committee.

Researchers wishing to use the data
should build in plenty of time into their schedule since it takes time to
process applications and prepare data sets. Researchers will need to do as much
work to help define their search criteria as possible and we are developing
web tools to help with this. Researchers will, however, need to enlist
clinical GP support in their institution to help define case definition
for their searches.

QRESEARCH releases data to academics
employed by UK universities to undertake bone fide research. We assess
eligibility of applications using the following questions.

Did you have the original
idea for this research project?

To your knowledge is this
work original and capable of publication as original research in a peer-
reviewed journal?

Are you free to undertake
this study and publish its findings without needing to clear it with the
funding source or any other organisation?

Do you agree to acknowledge
the source of QRESEARCH data in any publication, paper, report or software/tool?

Do you agree NOT to attempt
to identify patient(s) or practice(s)?

Do you undertake to provide
a copy of the final report of the project and copies of any publications
within one year of the project completion?

Do you agree NOT to release the
data to any third party including the funder, sponsor or other such body?

Do you agree not to use the
data for any other project except that which is expressly described in
your protocol

Do you undertake to check
the data you are given within a month of receipt and report back any
problems within that time?

Do you have a statistician
on the project team who has contributed to the design of the study and
will advise on the analysis?

Do you agree to have a project summary on the QReserch website once the project starts?

An answer of ‘no’ to any of the
questions is likely to invalidate the application.

If you are an academic employed by a
UK university, please read the following information and also look at the
publications page for examples of studies which have been undertaken.

How does it work?

Researchers originate a research
question or hypothesis; write an outline protocol; and contact QRESEARCH to
discuss the feasibility of undertaking the study. If the study is feasible,
QRESEARCH will give an broad estimate of the costs of providing the data and
will provide a letter to accompany any application for funding. The researcher
then secures the necessary funding and completes the QRESEARCH application
form, including a detailed protocol and data specification. This application is
sent for scientific review and feedback is given to the researcher. The
researcher makes any necessary modifications to the protocol and approval
is obtained, the researcher is given a timescale for the data extraction. Once
the researcher has the data, they have to approve it within one month of
receipt.

How much does it cost?

QRESEARCH is not-for-profit and is entirely self-funding so needs to
cover the costs associated with providing a research service. We will estimate
the cost of each data extraction plus VAT. The estimate will take account of
the complexity of the data required and the time taken to extract it. If the
specification becomes more complex, then the cost will be uplifted. QRESEARCH
will submit an invoice to the Principal Investigator for the work concerned.
This will be paid in advance of the data being extracted.

Who is eligible to apply for research
access?

QRESEARCH was established
specifically to provide access for research projects by academics employed by
UK universities. A license agreement will be between QRESEARCH and the
employing University. At least on member of the research team must be a
medically qualified academic registered with the General Medical Council who
signs the guarantee.

What types of studies are most
suitable?

We will provide extracts of data on
samples of patients with sufficient data to be able to test the hypothesis. The
sample size will depend on the sample size calculation. We do not license the
use of the whole database. Any research analyses which might involve the whole
database or which need a practice level analysis need to be done on site and
are subject to QRESEARCH having adequate capacity.

The following studies are most
suitable:

·Case control studies designed to examine risk factors for onset of
disease

·Cross sectional surveys

·Cohort studies

·Sample size calculations

Are there studies which cant be done
on QRESEARCH?

Yes, there are some types of studies
which are not suitable for QRESEARCH. The QRESEARCH team will let researchers
know at an early stage if a study is not suitable. In particular, QRESEARCH
cannot undertake studies which involve:

·any intervention on practices or patients

·any need to contact the practices or patients since this is impossible

What is the maximum number of
patients that wil be released in a dataset?

The number of patients in a sample
depends on the sample size calculation. The maximum is 100,000 patients.

What happens if a researcher
contravenes the conditions of using the database?

Attempts to break the confidentiality
of the practices or patients or clear evidence of research misconduct will be
treated extremely seriously by QRESEARCH and, if proven, will result in a bar
on further access to data for the research team and their university. It
will also lead to referral to the General Medical Council which is why one of
the core teams needs to be registered with the GMC.

What if a pharmaceutical company
wants to access data for research?

QRESEARCH does not provide data for
pharmaceutical companies except where there is a clearly defined concern
regarding the safety of a drug. In these circumstances the pharmaceutical company
will be referred to a third party appointed by QRESEARCH to handle such
requests.The normal governance procedures will be followed so that the analysis
independent and published.

Does QRESEARCH mind where the funding
for my study has come from?

We ask you to declare the source of
funding and we ask you to guarantee all the conditions above. All applications
are reviewed by the Scientific Board and the MREC and if there are concerns
then we will discuss it with you. If a researcher wishes to apply for funding
for an application which has already been apporved, and the grant application
is based on, or contains reference to QRESEARCH data, QRESEARCH
must be informed by email about the application before the application is
submitted.

Duplication of academic studies

QRESEARCH will inform prospective
researchers if their project [or one very similar] is already being undertaken
by another team in order to avoid duplication whilst maintaining
confidentiality for both original team. We do not supply the same or very
similar data to different teams to answer very similar questions. We also hope
this will avoid disappointment and wasted effort by one team if the other team
publishes first. However, if the second team can come up with good reasons why
the analyses need to be performed again, then the QRESEARCH Scientific Board
will be asked to consider the best way forward.

Non Exclusivity

QRESEARCH undertakes research and analysis for a variety of
organisations covering a wide scope of questions including both research and
audit. Nothing in any agreement with a third party will prevent QRESEARCH from
supplying data and services to any other party at any time. At all times
copyright in core material from the QRESEARCH database licensed by any client
remains the absolute property of QRESEARCH.

What happens to the results of
research projects?

We expect research to be published in peer-reviewed journals. Every form
of publication arising from the work utilising the QRESEARCH database shall
acknowledge it as the source of the raw data in keeping with the conditions of
access to the database. Publications should also refer to the version of the
database and the date of last data download for the data used in the study.

What criteria are used for the
Scientific review?

The Scientific Board judge
applications against the following criteria

1.Is there a clear research question or hypothesis which is likely to lead
to a generalisable findings capable of publication in a peer reviewed medical
journal?

2.Are the researchers likely to be able to conduct the study and it
analysis?

3.Is QRESEARCH the appropriate database to be used to conduct the
research?

4.Is the methodology appropriate to answer the question (including the
possibility of bias and confounding)?

5.Are there any potential risks to the ethical position of QRESEARCH in
undertaking this research (including the potential identification of patients
or practices)?

6.Do you have any conflict of interest in reviewing this application? If
so, please give brief details?

7.Overall do you think QRESEARCH should approve this research project??

Why do we need to secure funding first?

We get many
of enquiries from academics who then don’t proceed to undertake the project.
This can be for a variety of reasons including a failure to identify the
necessary funds. Our Scientific Board is unpaid and so we only ask them to
review projects which are almost certainly going ahead. We ask the Scientific
Board to review them before the MREC to ensure that the protocol which then
goes to MREC doesn’t need to be amended and hence re-submitted.

I just want all the data for the patients of interest. Is this OK?

No. We expect
researchers to have a specific research question/hypothesis that requires
specific data. We do not license the whole database or give out entire medical
records. The maximum number of patients which can be supplied is 100,000 and
will usually be less than this.

What do I need to do if my research question changes?

The approval
you gain is on the basis of the protocol submitted to the Scientific Board. If
you would like to answer another research question which is not in your original
protocol then you must re-submit it as a new project for peer review. An
additional charge is likely since data are licensed on a per study
basis.

.

What happens if my research team changes or I move institutions?

QRESEARCH data may onluy be
accessed by individuals and organisations and for the purposes of the
research which has been approved. You may not transfer, distribute, share, sell
or sublicense the data to any third party. Specifically, you may not transfer
the data outside the UK. Shuld there be any changes in the individuals or
organisations undertaking the research, you must notify QRESEARCH so
that an amended data agreement can be negotiated.

What if I don’t want to do the research but I want to know the answer?

QRESEARCH may
also do commissioned research if appropriate. This can be done in collaboration
or as a service for which QRESEARCH will give a formal quote. QRESEARCH has a
standard draft contract for this type of work which is available on request.

Is there an appeal process if my application to QRESEARCH is not
approved?

Reasons for
refusal for an application include failure to comply with the essential
criteria noted above or because the application fails to pass the scientific
review process. It could also include failure by the applicants to produce
academic papers from previous studies where QRESEARCH data has been supplier.
Should an application be rejected, the applicant is welcome to make the
appropirate changes and submit a new application which would be expected to be
substantially different to the original one. A covering letter documenting the
reason for the appeal, what reasons had been given by QRESEARCH for the
rejection, what actions and amendments had been undertaken. A charge for
processing the application may be raised to cover the cost of administering the
appeal.

What happens if there is a mistake in the data?

QRESEARCH will take
every precaution to ensure that the data requested match the exact
specification which has been agreed and signed off by the principal
investigator. The data extraction process will be subject to routine quality
assurance procedures. It is the principal investigator’s responsibility to
confirm receipt of the data and check the data and notify QRESEARCH of any
errors or omissions within 28 days. In the absence of any such notification we
shall consider that the data are correct. If there is a mistake in the data,
then the principal investigator should contact QRESEARCH who will investigate the problem.

If there is a mistake in the data extraction caused by QRESEARCH error,
then the principal investigator will be provided with a corrected dataset
within 28 days or as soon as is reasonably possible. QRESEARCH cannot be liable
for the cost of any staff time spent working on the data.

If the mistake is due to an error in the data specification drawn up by
the researchers (eg the researchers have selected the wrong Read codes), then
QRESEARCH will endeavour to help by re-running the data extraction routine with
the new codes within the following 3 months. There will be an additional cost
for this.

Publication of results

The results
of all studies using QRESEARCH data must be published and the results must be
publically available to maximise the public benefit but also to reduce the risk
of publication bias. The underlying individual level data for the paper must
not be shared under any circumstances. Requests to access the individual level
data must be directed to QRESEARCH who will consider the request as a new
application. Researchers must consider the risk of identifying
individuals in their analysis prior to publication and must not publish small
numbers (which are counts 1-5). A higher level of aggregation should be
considered when analyses produce less than 5 cases.

How long do I have to undertake my research?

We will write
to you after two years to invite you to submit for an extension to continue to
use the data or to ask you to destroy the data if the project has finished and
provide a report on the study.